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    Senior Scientist, Vaccine MSAT - Boston, United States - HireMinds

    HireMinds
    HireMinds Boston, United States

    5 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Senior Scientist, MSAT Upstream

    Boston, MA

    Our vaccine client here in Boston, MA is looking to add a Sr. Scientist, MSAT Upstream (onsite) to support their recombinant vaccine program This role will be key in supporting vaccine tech transfer and process development. You will provide expertise for the scale-up, tech transfer, and validation of upstream cell culture and viral vector unit operations in support of clinical/commercial manufacturing.

    Responsibilities:

    • Develop and execute lab studies to support life cycle management and continuous improvement initiatives.
    • Drive process characterization studies to map design space (PARs and NORs) at the CDMOs
    • Working with internal resources to identify potential improvements for existing upstream processes.
    • Perform gap assessments and design mitigation plans and studies in collaboration with CDMOs to derisk Manufacturing runs
    • Trend process data for ongoing batches and communicate to senior leadership
    • Assess process data and develop and/or recommend product specification ranges
    • Serve as a subject matter expert for Upstream unit operations to both internal and external stakeholders.
    • Support ongoing technical transfer and manufacturing at CDMOs through acting as person in plant, and providing technical oversight to assist with troubleshooting.
    • Support Root cause investigations and deviation management in partnership with Quality
    • Providing technical input to the Quality organization with regards to CAPAs as needed
    • Overseeing, developing, and managing external and internal cross-functional activities required to advance vaccine manufacturing goals.
    • Supporting development and commercial operations groups in the preparation of relevant regulatory filings.
    • Generate criticality assessments, Product quality risk assessments and lead FMEAs at the CDMO to support large scale tech transfer cross functionally.

    Education, Experience & Skills:

    • Masters or PhD in Chemical Engineering, Pharmaceutical sciences or equivalent. PhD is preferred.
    • A minimum of 5 years experience (PhD) or MS and a minimum of 8 years experience in mammalian or insect cell culture for the production of VLPs or other similar recombinant proteins.
    • Direct experience with recombinant VLPs or vaccines is highly desirable.
    • Some experience working with CDMOs is a nice to have
    • Developed leadership skills and the ability to communicate business objectives as well as technical information effectively.
    • Proven experience in managing and coordinating both internal and external deliverables.
    • Demonstrated technical expertise in production of recombinant proteins utilizing transient or stable transfections in mammalian or insect cell lines.
    • Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing.
    • Proficiency in statistical software (JMP, R, etc) for data analysis, DOE, and tracking and trending
    • Demonstrated ability to work efficiently across multiple project teams and business functions.

    Other:

    • On-site 2-3 days per week
    • Willingness to travel to various meetings or client sites, including overnight trips (domestic and international). Up to 10-20%
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